Sling assembly with secure and convenient attachment

ABSTRACT

A surgical assembly for treating fecal incontinence can include an elongate needle, a sling and a coupler to conveniently and securely connect the coupler to an insertion end of the needle by moving the coupler and insertion end of the needle together.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 10/616,938 filed Jul. 11, 2003 now U.S. Pat. No. 7,112,171,which is a continuation of U.S. patent application Ser. No. 09/990,108,filed Nov. 21, 2001 now U.S. Pat. No. 6,641,525, which is acontinuation-in-part of U.S. patent application Ser. No. 10/005,837,filed Nov. 9, 2001 now abandoned and U.S. patent application Ser. No.09/917,443 filed Jul. 27, 2001 now U.S. Pat. No. 6,612,977 and U.S.patent application Ser. No. 09/917,562 filed Jul. 27, 2001 now U.S. Pat.No. 6,652,450 and claims priority thereto and of U.S. ProvisionalApplication Ser. No. 60/263,472, filed Jan. 23, 2001; and U.S.Provisional Application Ser. No. 60/269,829, filed Feb. 20, 2001, andU.S. Provisional Application Ser. No. 60/281,350, filed Apr. 4, 2001;and U.S. Provisional Application Ser. No. 60/295,068, filed Jun. 1,2001, and U.S. Provisional Application No. 60/306,915, filed Jul. 20,2001, and U.S. Provisional Patent Application 60/332,330, filed Nov. 20,2001, entitled, “Sling Assembly Articles” (all of whose contents arefully incorporated herein by reference).

BACKGROUND

Urinary incontinence is a significant health concern worldwide.Incontinence may occur when the pelvic floor weakens. There are fivebasic types of incontinence: stress incontinence, urge incontinence,mixed incontinence, overflow incontinence and functional incontinence.There are a large number of surgical interventions and procedures foraddressing incontinence.

Some surgeons are slow to adopt promising new surgical techniques fortreating incontinence for a variety of reasons. Some are simplyunwilling to try new instrumentation that seems unfamiliar. Others mayfind new instrumentation inconvenient or awkward.

A variety of surgical procedure options are currently available to treatincontinence. Depending on age, medical condition, and personalpreference, surgical procedures can be used to completely restorecontinence. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling procedure.

A sling procedure is a surgical method involving the placement of asling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Descriptions of different slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

Sling procedures differ in the type of material used for the sling, themethod of anchoring the sling material in the body and how the slingmaterial is inserted in the body. The time required for a surgicalprocedure varies, but is preferably as short as possible. This factor isfrequently reported in urology and gynecology literature. See AthertonM. J., et al., A Comparison of Bladder Neck Movement and Elevation AfterTension-free Vaginal Tape and Colposuspension, British Journal ofObstetrics and Gynaecology, Nov. 2000, Vol. 17, p. 1366-1370, Nilsson etal, The Tension-free Vaginal Tape Procedure is Successful in theMajority of Women with Indications for Surgical Treatment of UrinaryStress Incontinence, British Journal of Obstetrics and Gynaecology,April 2001, Vol. 108, P. 414-419; and Ulmsten et al., An AmbulatorySurgical Procedure Under Local Anesthesia For Treatment of FemaleUrinary Incontinence, Int. Urogynecol. J. (1996), v. 7, pps. 81-86.

Although serious complications associated with sling procedures areinfrequent, they do occur. Complications include urethral obstruction,development of de novo urge incontinence, hemorrhage, prolonged urinaryretention, infection, and damage to surrounding tissue and slingerosion.

The Tension-free Vaginal Tape (TVT) procedure (available from Ethicon,of N.J.) utilizes a Prolene™ nonabsorbable, polypropylene mesh. The meshis a substantially flat, rectangular knitted article. The mesh includesa plurality of holes that are sized to allow tissue ingrowth to helpavoid infection. A plastic sheath surrounds the mesh and is used toinsert the mesh. During the sling procedure, incisions are made in theabdominal (i.e. suprapubic) area and in the vaginal wall. Two curved,relatively large (5 mm or larger) needle-like elements are eachconnected to an end of the vaginal sling mesh. A sling-free, sharp tipend of one of the needle-like elements is initially pushed through thevaginal incision and into the paraurethral space. Using a handleattached to the needle, the needle is angulated laterally (for example,to the right) to perforate the endopelvic fascia, pushed through theretropubic space and passed through the abdominal incision. The handleis disconnected and the needle is then withdrawn through the abdominalwall, thereby threading a portion of the sling through the tissue of thepatient. The handle is then connected to the other needle and thetechnique is repeated on the contralateral side, so that the mesh islooped beneath the bladder neck or urethra. The sling is positioned toprovide appropriate support to the bladder neck or urethra. At the endof the procedure, the sling ends are cut at the abdominal wall, thesheath is removed and all incisions are closed.

Complications associated with the TVT procedure and other known slingprocedures include injury to blood vessels of the pelvic sidewall andabdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. One serious disadvantage of theTVT procedure, particularly for surgeons unfamiliar with the surgicalmethod, is the lack of information concerning the precise location ofthe needle tip relative to adjacent pelvic anatomy. A cadaver study hasindicated that the TVT needle is placed in close proximity to sensitivetissue such as superficial epigastric vessels, inferior epigastricvessels, the external iliac vessel and the obturator. See, Walters, MarkD., Percutaneous Suburethral Slings: State of the Art, presented at theconference of the American Urogynecologic Society, Chicago (October2001).

If the TVT needle tip is allowed to accidentally pass across the surfaceof any blood vessel, lymphatic duct, nerve, nerve bundle or organ,serious complications can arise. These shortcomings, attempts to addressthese shortcomings and other problems associated with the TVT procedureare disclosed in PCT publication nos. PCT WO 00/74633, PCT WO 00/74613and PCT WO 00/74594.

Additional problems are associated with the TVT procedure. Removal andreuse of the handle of the TVT product is a cumbersome, time consumingprocess, requiring the surgeon to manually rotate the handle until thehandle is unscrewed from the needle. Reusing the handle presents acontamination risk, particularly if the handle and screw threads are notproperly cleaned and sterilized after use on the patient.

BRIEF SUMMARY

The present invention includes surgical instruments, articles andprocedures for urological applications, particularly incontinencesurgical procedures.

In one aspect, the present invention comprises a surgical assembly fortreating incontinence. The assembly comprises an elongate needle, asling and a coupler. The needle is sized and shaped to be initiallyinserted through an abdominal incision and to then emerge from a vaginalincision. The needle has an insertion end and an end opposite theinsertion end. The insertion end of the needle is preferably blunt. Thesling is constructed of a material that is capable of being implantedduring the incontinence procedure.

The coupler has an elongate body with an axis. The body has a first endand a second end with surfaces for conveniently and securely connectingthe coupler to the insertion end of the needle by moving the coupler andinsertion end of the needle together in a substantially axial fashion.

The coupler is convenient and easy to connect to the needle. Preferably,the assembly has an Insertion Force (described in greater detail below)of no more than about fifteen pounds. More preferably, the InsertionForce is no more than about ten pounds. Even more preferably, theassembly has an Insertion Force of no more than about eight pounds.

Once the coupler and needle are connected, they should not separate,especially within the body. Preferably, after the needle is connected tothe coupler, the assembly has a Separation Force (described in greaterdetail below) of at least about fifteen pounds, more preferably of atleast about thirty pounds.

In another aspect, the present invention comprises the coupler describedabove. The first end of the coupler connects to a first needle. Thesecond end of the coupler can be associated with a sling, insertionsheath or both.

Optionally, the coupler can comprise a needle adapter for connecting afirst needle to a second needle. In this embodiment, the second end ofthe coupler receives an end of a second needle so that the coupler andfirst needle may guide the second needle through the body.

In another aspect, the present invention comprises an improved method oftreating incontinence in a female patient. The method comprises thesteps of: i) providing a surgical mesh, and a removable syntheticinsertion sheath, ii) providing a needle that is sized and shaped to beinitially inserted through a suprapubic incision and to then emerge froma vaginal incision, iii) providing a coupler having an axis, the couplerhaving a first end and a second end with surfaces for conveniently andsecurely connecting the coupler to an insertion end of the needle, iv)creating at least one vaginal incision, v) creating at least onesuprapubic incision, vi) passing the leading end of the needle initiallythrough the suprapubic incision and then through the vaginal incision,vii) then connecting the coupler to the needle by moving the coupler andinsertion end of the needle together while the insertion end of theneedle protrudes from the vaginal incision, viii) implanting the slingby moving the leading end of the needle from the vaginal incision towardthe suprapubic incision, and ix) then removing the synthetic insertionsheath.

Preferably, the step of connecting the coupler to the needle by movingthe coupler and insertion end of the needle together includes the stepof: pushing the coupler onto the insertion end of the needle in asubstantially axial fashion.

In another aspect, the present invention comprises an improved surgicalmethod including the steps of i) providing a first needle that is sizedand shaped to be initially inserted through an abdominal incision and tothen emerge from a vaginal incision, the needle having an insertion endand an end opposite the insertion end, ii) providing a coupler having anaxis, the coupler having a first end and a second end with surfaces forconveniently and securely connecting the coupler to the insertion end ofthe needle, iii) providing a second needle that is sized and shaped tobe initially inserted through a vaginal incision and to then emerge froman abdominal incision; the second needle being attached to a syntheticsurgical mesh, and a removable synthetic insertion sheath, iv) creatingat least one vaginal incision, v) creating at least one abdominalincision, vi) initially passing the first needle through the abdominalincision and then through the vaginal incision, vii) connecting thesecond end of the coupler to the insertion end of the first needle,viii) connecting the first end of the coupler to the second needle; andix) guiding the second needle from the vaginal incision to the abdominalincision with the first needle to implant the sling.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a perspective view of one embodiment of assembly according tothe present invention;

FIG. 2 is a perspective view of a coupler according to the presentinvention,

FIG. 3 is a top view of the coupler shown in FIG. 2;

FIG. 4 is a side view of the coupler of FIG. 2;

FIG. 5 is top view of the coupler shown in FIG. 2, similar to the viewshown in FIG. 3, but showing different reference characters;

FIG. 6 is a sectional view of the coupler of FIG. 5;

FIG. 7 is a side view of a coupler associated with a sling or a slingassembly;

FIG. 8 is a sectional view of the coupler shown in FIG. 2, similar tothe view shown in FIG. 6, but showing different reference characters;

FIG. 9 is a perspective view of a needle according to the presentinvention;

FIG. 10 is an end view of a needle according to the present invention;

FIGS. 11 and 12 are side schematic views wherein:

FIG. 11 shows a needle being inserted into a coupler according to anInsertion Force Test; and

FIG. 12 shows a needle attached to the coupler and a Separation ForceTest according to the present invention;

FIGS. 13 through 17 are perspective views sequentially showing theinsertion of a needle suprapubically in accordance with one aspect ofthe present invention, wherein:

FIG. 13 shows the needle just passing an abdominal incision;

FIG. 14 illustrates the needle as the surgeon seeks to identify thetactile feel of the resistance provided in part by the posterior portionof the pubic bone;

FIG. 15 shows the needle as it passes along the posterior surface of thepubic bone which may be used as an anatomical guide for a surgeon as theneedle approaches a vaginal incision;

FIG. 16 illustrates the needle as it passes out of a vaginal incision;

FIG. 17 is a perspective view of a sling attached to two needlesaccording to an embodiment of the present invention;

FIG. 18 is a perspective view of a sling being pulled upward inaccordance with the present invention,

FIG. 19 is a perspective view of the sling according to the presentinvention after the couplers have been separated from the rest of theassembly, but prior to final trimming;

FIG. 20 is a perspective view of the sling according to the presentinvention after the sheath has been removed and the sling has beentrimmed; and

FIG. 21 is a perspective view of a first needle after it has beeninserted suprapubically and emerges from a vaginal incision, a couplerconnected to the first needle after the needle has been insertedsuprapubically, and a second needle for implanting a sling that isassociated with the other end of the coupler in preparation for beingmoved through the patient.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

The present invention is directed to surgical instruments, andimplantable articles for treating medical disorders such as incontinenceor stress urinary incontinence (SUI) in both men and women. The presentinvention is also directed to improved surgical procedures that utilizethe surgical articles. Although the invention as disclosed hereingenerally refers to SUI, treatment of other urological disorders, suchas urge incontinence, fecal incontinence, mixed incontinence, overflowincontinence, functional incontinence, prolapse (e.g. vaginal anduterine), enteroceles (e.g. of the uterus or small bowel), rectoceles,cystoceles and other disorders are also included within the scope of thepresent invention. It is contemplated that the present invention mayalso be utilized in conjunction with concomitant procedures, such as,but not limited to, procedures for addressing cystocele, rectocele,vaginal prolapse and anatomic corrections.

In one aspect, the present invention comprises an assembly 40 for use insurgery. FIG. 1 illustrates a sling 42, a needle 60 and a dilator orcoupler 54.

The needle 60 is preferably sized and shaped to pass initially throughan abdominal incision and then emerge through a vaginal incision.Typically, the needle will have an elongate body and a pair of ends 58and 62.

FIG. 9 illustrates a curved needle 60. The needle 60 is preferablyarc-shaped and includes end 58 and end 62. The ends or tip of the needle60 are preferably not sharp, but may be tapered to afford easy passagethrough tissue while providing a blunt surface that avoids cuttingsensitive tissue such as the bladder or urethra. In a preferredembodiment, the length of the needle 60 is approximately within therange of 16.5 cm to 24.1 cm (6.5 inches to 9.5 inches) and has apreferred external diameter of approximately 3.175 mm (0.125 inch).Preferably, the diameter of the needle 60 is small to reduce tissuetrauma and increase control.

The needle 60 is preferably made of a malleable, yet durable,biocompatable surgical instrument material such as, but not limited to,stainless steel (e.g. 316 stainless steel or 17-4 stainless steel),titanium, Nitinol, polymers, plastics and other materials, includingcombinations of materials. The needle 60 should have sufficientstructural integrity to withstand the various forces (e.g. forces causedby coupler attachment, and penetration/passage of the needle 60 throughthe various tissues) without undergoing any significant structuraldeformation. Optionally, the needles 60 could be sufficiently malleableto allow a practitioner or user of the device to modify the needle 60 toa desired shape and, thereby, optimize the procedural approach.

In another aspect of the present invention, different types of needlesmay be provided that need not serve the same purpose in a surgicalprocedure. FIG. 21 illustrates a suprapubic needle 602 (e.g. with apreferred diameter of about 4 mm, or less, more preferably about 3 mm)and a relatively larger sling associated needle 604 (e.g. with adiameter of 5 mm). Preferably, the sling associated needle has a slingassembly 610 (e.g. a sling mesh and insertion sheath) attached thereto.

The suprapubic needle 602 serves a different purpose than the slingassociated needle 604. The suprapubic needle 602 is preferably small andhas a blunt tip. The blunt tip is initially inserted through anabdominal or suprapubic incision 400 and then through a vaginal incision404. Inserting a small, blunt needle in this fashion provides thesurgeon with addition control in maneuvering through the anatomy of apatent and in avoiding sensitive tissue.

A surgical assembly according to an aspect of the present invention mayinclude a coupler 54 adapted to be snapped onto the end of needle 602.The sling associated needle 604 may optionally include a sharp tip. Thecoupler receives the tip or end of the needle 604. Pushing upward on thesling associated needle 604 (e.g. with one hand) while optionallysteering or guiding the tip of the needle 604 by holding needle 602(e.g. with the other hand) is believed to provide better control overinsertion of a prior art large needle that is initially inserted throughthe vaginal incision 404 and then through the suprapubic incision.

Alternatively, the coupler and/or needle 604 can include surfaces forfirm engagement and attachment between coupler and needle 604. Thosesurfaces can include mechanical interlocking structures, graspingstructures or interference structures. Optionally, a biocompatibleadhesive may be used to adhere the tip of sling associated needle 604 tothe coupler/adapter.

Referring again to FIG. 1, the assembly includes a sling material 42(e.g. as part of the sling assembly 46). As used herein, the terms“sling” or “article” or “mesh” or the phrases “implantable material” or“implantable article” or “sling mesh” (or combinations thereof) are usedgenerally to describe a variety of materials including synthetic andnon-synthetic materials. Typically, the implantable article will beelongate and substantially flat. It can be used as a hammock, sling,strip or support member. Optionally, the sling 42 can include a slingtensioning member 66 (e.g. as disclosed in U.S. patent application Ser.No. 09/917,562, filed Jul. 27, 2001).

While the sling 42 is preferably rectangular for treating SUI infemales, other shapes are also contemplated. Depending on the treatmentaddressed (e.g. to provide hammock support for the bladder or bladderneck, or to address a rectocele, enterocele or prolapse) the slings maybe any of a wide variety of shapes. As an example, the sling may be ofthe general shape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).

Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia and fascia lata.

Suitably synthetic materials for a sling include polymerics, andplastics and any combination of such materials may also be used in a kitof the present invention. Commercial examples of such materials includeMarlex™, Prolene™, and Vaskutek™. Other examples of suitable materialsinclude those disclosed in U.S. patent application Ser. No. 09/939,098filed Aug. 24, 2001 (the entire contents of which are hereinincorporated by reference). Specific examples of synthetic slingmaterials include, but are not limited to polypropylene, polyethylene,nylon, PLLA and PGA.

The sling material may be resorbable, absorbable or non-absorbable.Optionally portions may be absorbable and other portions may benon-absorbable.

In one aspect of the invention, the sling 42 may comprise a meshmaterial. The mesh material comprises one or more woven, knitted orinter-linked filaments or fibers that form multiple fiber junctionsthroughout the mesh. The fiber junctions may be formed via weaving,knitting, braiding, bonding, ultrasonic welding or other junctionforming techniques, including combinations thereof. In addition, thesize of the resultant openings or pores of the mesh may be sufficient toallow tissue in-growth and fixation within surrounding tissue. As anexample, not intended to be limiting, the holes may comprise polygonalshaped holes with diagonals of 0.132 inches and 0.076 inches. Holes muchsmaller than this are not preferred as they may facilitate bacterialcolonization.

The quantity and type of fiber junctions, fiber weave, pattern, andmaterial type influence various sling properties or characteristics.Non-mesh sling configurations are also included within the scope of theinvention. As another example, not intended to be limiting, the mesh maybe woven polypropylene monofilament, knitted with a warp tricot. Thestitch count may be 27.5 courses/inch (+ or −2 courses) and 13wales/inch (+ or −2 wales). The thickness of this example is 0.024inches.

In another embodiment the sling material may have one or more substancesassociated therewith through a process such as coating. Examples ofappropriate substances include, without limitation, drugs, hormones,antibiotics, antimicrobial substances, dyes, silicone elastomers,polyurethanes, radiopaque filaments or substances, anti-bacterialsubstances, chemicals or agents, including any combinations thereof. Thesubstances may be used to enhance treatment effects, reduce potentialsling rejection by the body, reduce the chances of tissue erosion,enhance visualization, indicate proper sling orientation, resistinfection or other effects. For example, the sling may be coated by theprocess described in U.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745;5,902,283 and 6,162,487 (the entire contents of which are herebyincorporated by reference).

FIG. 1 illustrates a sling assembly comprising sling 42 and sheath 44that are made of biocompatible materials having sufficient strength andstructural integrity to withstand the various forces exerted upon thesecomponents during an implant procedure and/or following implantationwithin a patient.

Preferably, the overall dimensions of the sling assembly 46, includinginsertion sheath 44 and sling 42 are sufficient to extend from anabdominal incision, to an undersurface of the urethra and back toanother abdominal incision with additional size to account for theimprecision associated with the range of human anatomy sizes. In apreferred embodiment, the sheath length of the assembly of the presentinvention is approximately within the range of 52.0 cm to 58.5 cm (20.5inches to 23.0 inches), sheath width is approximately within the rangeof 1.0 cm to 1.63 cm (0.482 inch to 0.642 inch) and sheath materialthickness is approximately within the range of 0.127 mm to 0.203 mm(0.005 inch to 0.008 inch), respectively. The associated sling 42 has alength, width and thickness approximately within the range of 40 cm to51 cm (15.7 inches to 20.1 inches), 1.0 cm to 1.2 cm (0.394 inch to0.472 inch) and 0.508 mm to 0.711 mm (0.020 inch to 0.028 inch),respectively.

The sling 42 of the present invention can be implanted without the needfor bone screws. Upon implantation, a portion of the sling 42 is passedand/or woven through various layers of abdominal/pelvic tissue.

The sling 42 is designed to remain within the body of a patient as animplant for a predetermined therapeutically effective amount of time.The sling may be non-absorbable, absorbable or resorbable, including anycombinations of these material properties, depending on the desiredtreatment. The general characteristics of the sling material and designshould be such as to withstand the various forces exerted upon it duringimplantation (for example, frictional forces associated with tissueresistance) and after implantation (for example, increased abdominal orbladder pressure caused by a stress event).

The precise, final location of the sling 42 will depend on a variety offactors including the particular surgical procedure(s) performed, andany preconditions of the patient such as scar tissue or previoussurgeries. For example, it may be preferred to place the sling 42 inclose proximity to, but not in contact with, a mid portion of theurethra to treat incontinence.

According to one embodiment, the sling may include a protective sheath44 (see FIG. 1). The sheath 44 is used during insertion of the strip 42.After the sling 42 is implanted, the sheath 44 is removed and discarded.Preferably, the protective sheath 44 is constructed of a material thataffords visual examination of the implantable sling material 42 and thataffords convenient passage of the assembly 46 through tissue of thepatient.

In a preferred embodiment, the sheath 44 is made of polyethylene. Othermaterials including, without limitation, polypropylene, nylon, polyesteror Teflon may also be used to construct the sheath 44. The sheathmaterial should be flexible and provide sufficient structural integrityto withstand the various forces exerted on the sheath 44 throughout thesling delivery procedure. In general, the sheath 44 is configured tohave sufficient flexibility to facilitate user manipulation and adequatestructural strength to withstand the various forces applied to thesheath 44 during delivery and/or positioning of the sling assembly 46.It should also conveniently separate from the sling material 42 afterthe sling 42 is implanted without materially changing the position ofthe sling 42.

The sheath 44 may comprise two elongate, separable sections. Optionally,portions of the sheath 44 may detachably and telescopically overlap nearthe middle portion of the sling. In addition to resisting sling exposureand contamination, the overlapping section may also be used as a visualindicator for the practitioner or user of the device. Additionally,orientation indicia (not shown) may be placed on the overlapping portionto indicate proper orientation of the sling relative to the urethra.Alternatively, other configurations of the sheath 44 are within thescope of the present invention. In particular, the sheath may be unitaryas opposed to telescoping with perforations, slits, holes, scores ortear lines designed to allow separation and removal of the sheath 44.

During sheath removal, the first section and the second section of thesheath are slid off the sling 42 by pulling each end of the sheath 44away from the middle portion of the sling assembly 46. Removal of thesheath 44 causes separation of the overlapping sheath sections, therebyexposing the sling 42. In addition, the smooth outer surface of thesheath 44 provides a relatively frictionless surface to facilitatepassage of the sheath 44 through the various tissues. The relativelyfrictionless motion also avoids disturbing the position of the sling 42relative to the anatomy of the patient.

In another embodiment of the invention, the sheath 44, or a portionthereof, is associated with one or more substances including thosesubstances identified with respect to sling 42. The substances may beused to enhance sheath removal, identify twists along the sheath 44 (andthereby indicate proper sling orientation), indicate cutting/separationpoints, indicate center-point, resist infection or provide otherdesirable effects. For example, a first surface of the sheath 44 mayinclude indicia that should lie opposite the urethra or bladder neck toensure proper sling orientation. Thus, the indicia provide thepractitioner/surgeon with a visual indicator to aid in properlyorienting the sling assembly 46, and ultimately the sling 42, within thepatient.

In another aspect, the present invention comprises a coupler (e.g. 54,FIG. 1) for use in a surgical sling procedure. Referring to FIGS. 2through 8, the coupler 54 comprises a body portion having first endportion 56 and second end portion 52 opposite the first end portion 56.The first end portion 56 has surfaces for receiving the insertion end ofa needle (e.g. end 58 of needle 60). The coupler also includes aninternal passageway with structure for connecting the needle 60 to thecoupler 54.

Referring to FIG. 16, the coupler 54 is attached to the insertion end 58of needle 60 after the end 58 emerges from a vaginal incision 404. Theconnection between the needle 60 and the coupler 58 is accomplishedquickly by pushing the coupler onto the end of the needle in asubstantially axial fashion. As used herein, when it is said that theneedle and coupler are moved together in a substantially axial fashion,it is meant that the motion is substantially linear with slightcurvatures being with the scope of the invention. Preferably, the motionis substantially parallel with the axis of the coupler, taking intoaccount that the coupler and/or needle may have a slightly curved axis.Connecting the needle and coupler in a substantially axial fashion, asopposed to articles that connect by being screwed together, is believedto be less distracting and more convenient for a surgeon. This motion isalso believed to be less likely to cause the needle to deflect anddamage tissue.

The force required to connect the coupler 54 to the needle 60 should berelatively small to avoid distracting the surgeon. By relatively small,it is meant that the force required to connect the needle and couplershould not unduly tax the strength of a majority of people.

Preferably, there is a tactile sensation when the coupler 54 is fullyseated on the needle 60. The tactile sensation signals the surgeon thatthe needle 60 may be pulled upward through the body without separatingfrom the coupler 54.

The second end portion 52 of the coupler 54 has sling associationstructure for associating the article with a sling or another needle(see FIG. 21). The sling association structure may comprise a hole 90and a portion of internal passageway 96 near end 52.

Preferably, the coupler 54 comprises a dilator that dilates a track forease of sling introduction and positioning within the patient. End 58 ofthe needle 60 is preferably keyed to allow for convenient, secureattachment of the needle 60 relative to the coupler 54. In a preferredembodiment, the key feature resists rotation of the coupler 54 relativeto the needle 60.

The assembly preferably includes two couplers. The coupler 54atraumatically creates and/or expands the passageway through the tissuesfor sling assembly delivery. The coupler 54 is preferably short relativeto a needle 60 for ease of passage of the assembly and to reduce theoverall amount of tissue that is deflected at one time. Preferably, thecoupler is less than 2.5 inches in length, and more preferably, it isless than 1.5 inches in length. The maximum radius of a coupler 54 ispreferably less than 10 mm, more preferably less than 7.5 mm, even morepreferably less than 5 mm. The tip of the coupler 54 is preferablyblunt, as, in preferred embodiments, the leading tip of the coupler 54will pass through tissue that has already been pierced by a needle 60.

The coupler 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal,polypropylene, Delrin®, Acrylonitrile-Butadiene-Styrene (ABS),polyethylene, nylon and any combination of biocompatible materials.

The coupler 54 preferably includes internal surfaces shaped in apredetermined fashion to engage or abut complementary surfaces on needle60. In a preferred embodiment, the needle connector surfaces afford apermanent affixation between the coupler 54 and the needle 60. By“permanent affixation”, it is meant that it would be very difficult toseparate the coupler from the needle after they have become permanentlyaffixed.

After implantation of the sling 42, to separate the sling 42 from thecoupler 54/needle 60, the surgeon cuts an end of the sling 42 asdescribed more fully below. The needle/coupler attachment surfacespreferably afford quick and convenient attachment of the coupler 54 tothe needle 60 to avoid wasting time in the midst of a surgicalprocedure. In contrast to focusing on a tedious or difficult connectionof an article protruding from the body and another article, with thepresent invention, the surgeon can rapidly and securely attach theneedle 60 to coupler 54 simply by pushing the coupler 54 onto the needle60 in a substantially axial (preferably linear) fashion. The attachmentis secure to avoid separation of the needle 60 and coupler 54 while thecombination is passed through tissue.

As seen in FIGS. 1 through 9, the first and second ends 58 and 62 of theneedle 60 may include a keying feature affording secure associationbetween the needle and coupler 54 and/or sheath assembly 46. In oneembodiment, the keying feature comprises a recess 130 and/orsquare-shaped portion 126. As previously described, the recess 130 andsquare-shaped portion 126 are designed for complementary engagement tothe appropriate end of coupler 54.

The coupler 54 also includes a universal sling association structure(e.g. hole 90) for associating with a sling. Preferably, the coupler 54is preattached to the sling 42 and/or sheath 44 (or the combinationthereof), particularly if the sling is a synthetic material.

Referring to the embodiment of coupler shown in FIGS. 2 through 8, thecoupler 54 may be approximately 3.1 cm (1.2 inches) in length. Thecoupler 54 preferably includes a gentle taper 88 near its first end 56.The coupler is sized and shaped to provide atraumatic passage throughbody tissue. The taper 88 and relatively smooth outer surface of thecoupler 54 facilitate atraumatic passage of the coupler 54 and attachedsling assembly 46 through the various tissues of the patient. Thepresence of the coupler 54 preferably allows a gentle transition betweenthe diameter of the needle, to the shape of the coupler, and finally tothe sling assembly 46, as opposed to prior art assemblies, where thestructure of the sling assembly abruptly increases the profile of theneedle and thereby the size of the structure that must pass throughtissue.

Preferably, the second end 52 of the coupler 54 associates the couplerwith one end of a sling 42, or sheath 44 or sling assembly 46. Thesheath 44 or sling 42 is preferably attached to the coupler 54 via afirst opening or through-hole 90 located near the second end of thecoupler 54. In this embodiment, the opening 90 could receive a varietyof materials, such as fascia, autologous materials, synthetics, biologictissues and any other similar tissues, including any combinations.

In the embodiment shown in FIG. 1, the end portion 48 or 50 of one endof the sheath 44 is threaded through the opening 90 of the coupler 54and secured to the sheath 44, thereby forming a loop. The edge portion48 or 50 may be fastened onto the sheath 44 via ultrasonic welding,bonding, melting, suturing, sealing or other attachment techniques.Further, as shown in FIG. 2, the end 52 of the coupler 54 preferablyincludes a cut-away section 94 to provide room to receive sling assemblymaterial to reduce the overall profile of the sling assembly experiencedby tissue during sling passage. Therefore, when the sheath is attachedto the cut-away section, the additional sheath material is not apt tosignificantly increase the relative thickness, diameter or profile ofthe coupler 54.

Alternatively, for couplers 54 manufactured via some molding techniques,the end of the sheath 44 may be encased within and secured to the secondend 52 of the coupler 54 during the molding process. In yet anotherembodiment, the end of the sheath 44 may be fixedly attached within alongitudinal slot located near the first end 52 of the coupler 44 usingan adhesive, ultrasonic welding or other attachment techniques.

Referring to FIGS. 2-6, the first end 56 of the coupler 54 includes asecond opening or through-hole or lumen 96 that extends substantiallyinternally along the longitudinal axis of the coupler 54. The hole 96preferably extends the length of the coupler 54.

The lumen 96 has an internal diameter generally configured forconvenient attachment to a needle 60 or similar sling-delivery device.In one embodiment, the internal diameter of the second opening 96 of thecoupler 54 is approximately within the range of 0.239 cm to 0.318 cm(0.094 inch to 0.125 inch). A shoulder 98 located on the surface 100 ofthe second opening 96 of the coupler 54 and a complementary matingrecess located on the surface of the first end of the needle 60 securelyand permanently attach or lock the coupler 54 and needle 60 together.Once the needle 60 is inserted into the coupler 54, they are preferablynot separated thereafter. After the sling 42 is implanted, the connectedneedle 60 and coupler 54 are removed from the sling by cutting an end ofthe sling as described in greater detail below. Preferable, the needle60 and coupler 54 are discarded after the surgical procedure.

One or more longitudinal slots 102 located on the outer surface of thecoupler 54 and in communication with the second opening 96 allow thewall of the coupler 54 to expand in a radially outward direction whenthe first end of the needle 60 is inserted into the second opening 96 ofthe coupler 54. When the shoulder 98 of the coupler 54 passes the recessof the needle 60, the wall of the coupler 54 collapses around the needle60 as the shoulder 98 seats into the recess, thereby securing thecoupler 54 on the needle 60 and blocking separation of the coupler 54and needle 60.

Although the invention has been described in terms of a shoulder 98 andmating recess, alternative coupler-needle attachment mechanisms such asbumps, grooves, slots, wedges, detents and other mechanisms are alsoincluded within the scope of the claimed invention.

The coupler 54 preferably includes one or more relief ports 104 tofacilitate convenient needle connection. The relief ports 104 may beformed at the ends of the longitudinal slots 102 or at varioushigh-resistance locations along the coupler 54. The relief ports 104decrease the rigidity or resistance of radially outward expansion of thecoupler wall and reduce the amount of force required to insert orsecurely attach the needle 60 to the coupler 54. The relief portscontribute to a desired reduction in the force required to insert theneedle into the coupler 54. In yet another embodiment, superficial bandsor rings, arc-shaped slots, superficial grooves or other mechanisms mayprovide improved expansion or attachment characteristics.

A portion of the coupler 54 includes a taper 88 having a decreasingprofile toward the second end 56 of the coupler 54. The taper 88preferably gently cams tissue out of the path of the sling assembly 46as the sling assembly is inserted in the body. The taper 88 is alsosized and shaped to reduce the amount of friction or resistance as thedevice is drawn through the tissues of the patient. The amount of forcerequired to manipulate the device through the tissues is therebyreduced. This in turn provides the user of the assembly with additionalcontrol over device insertion and maneuverability through tissue andwithin the patient. In addition to tapered profiles, other couplerprofiles such as conical, flared, frusto-conical, pyramid-shaped,elliptical or other applicable profiles may also be used. Overall, theprofile of the coupler 54 is preferably configured to provide easydilation of the tissue to accommodate smooth passage of the sling42/sling assembly 46 and subsequent collapse of the surrounding tissueto securely anchor the sling 42 into the tissue (after sheath removal).

The assembly of the present invention optionally includes handles 64.The handles may have any of the structure and features described in U.S.patent application Ser. No. 09/917,443 filed Jul. 27, 2001 (the entirecontents of which are herein incorporated by reference).

Instead of a hole 90 in the coupler 54, another mechanism may beutilized to connect a coupler 54 to a surgical sling material, sheath orsling assembly.

Other accessories may also optionally be included in a kit according tothe present invention. For example, a surgical drape specificallydesigned for urological procedures such as a sling procedure may beincluded in a kit of the present invention. Such a drape is disclosed inU.S. patent application Ser. No. 09/749,254, filed Dec. 27, 2001 (theentire contents incorporated herein by reference). Alternatively, anarticle for objectively setting tension of the device, such as thosedescribed in U.S. patent application Ser. No. 09/968,239, filed Oct. 1,2001 (the entire contents of which are incorporated by reference) may beincluded in the kit.

The kits according to the present invention preferably include at leasttwo needles. Two or more needles reduce the need to reuse a needle at adifferent location with a patient, thereby eliminating crosscontamination issues. Additional needles, handles, couplers and otherelements may also be included for surgical convenience, for avoidance ofcontamination from one portion of the body to another, for ease ofmanufacturing or sterilization or for surgical requirements.

The individual elements of the kits of the present invention may bepackaged together, separately or in subassemblies depending on a varietyof factors such as shelf life and sterilization requirements. They maybe assembled at the manufacturing location or at the healthcarelocation. Any suitable sterilization procedure may be utilized tosterilize the contents of a kit. Suitable sterilization techniquesinclude, but are not limited to steam, ethylene oxide, electron beam,vapor (e.g. hydrogen peroxide or peracetic acid), or plasma procedures.

EXAMPLE 1

Needle/Coupler

A needle as shown in FIGS. 9 and 10 was constructed from 316 stainlesssteel. A coupler as shown in FIGS. 2 through 6 and 8 was injectionmolded from acetal (Texapol 5209). Table A lists some of themeasurements of the various features.

TABLE A Reference Character in Figures Length (inches) D 1.195 Y .031 C.235 A .139 Z .085 X .096 B .230 L .645 N 8.680 O .515 P 0.25 Q 0.13 R.094 S .060

Various additional construction details of the coupler and needle aredisclosed in U.S. Provisional Patent Application 60/332,330, filed Nov.20, 2001, entitled, “Sling Assembly Articles”, Inventors: Gary Rochleau,Johann (Hans) Neisz and Gary Nachreiner (the entire contents of whichare expressly incorporated by reference herein).

EXAMPLE 2

Insertion/Separation Force

FIGS. 10 and 11 are schematic illustrations of test equipment used torecord Separation Forces and Insertion Forces for a needle and couplers.Ten sterilized and aged couplers were provided in accordance withExample 1. A new coupler was used for each Insertion Force/SeparationForce test. A single needle was constructed in accordance withExample 1. The needle was used for each Insertion Force/Separation Forcetest.

The test equipment included an Instron, 200 lb Load cell, Torque Meterdevice. To obtain the Insertion Force, the needle was loaded into theload cell in the Instron device. The coupler was loaded into a holdingfixture (see FIG. 11). The fixture was clamped into the lower air gripof the Instron device. The needle was lowered down and inserted into thecoupler to align the needle and coupler but not to induce a load. Theneedle was then inserted substantially in the direction of the arrow inFIG. 11 at a rate of 0.5 in/sec into the coupler until it locked ontothe coupler. The Insertion Force was then recorded.

To obtain the Separation Force measurement, the needle was pulled out ofthe coupler in the direction of the arrow in FIG. 12 at a rate of 0.5in/sec. The Separation Force was then recorded.

The data for the Separation Force and the Insertion Force is recorded inTable B.

TABLE B Needle/Coupler Needle/Coupler Insertion Force (lbs.) SeparationForce (lbs.) 7.95 33.50 7.74 31.74 5.28 35.59 6.89 32.33 5.32 29.57 9.5330.82 6.17 30.93 8.86 30.86 7.58 34.40 6.96 29.52

An analysis of the data of Table B is provided in Table C.

TABLE C Needle Coupler Needle Insertion Coupler Separation Force (lbs.)Force (lbs.) Average 7.229 31.926 Standard 1.400 2.025 Minimum 5.27829.520 Maximum 9.530 35.590

The results show that the Insertion Force is sufficiently low to makethe needle/coupler attachment easy and convenient for almost every user,regardless of the individual's strength. Additionally, the separationforce is extremely high to resist undesired separation of the couplerand needle.

A cadaver study was also conducted to study the force required to pull acoupler through tissue. This was determined using a Chatillon forcemeasurement device on a needle assembly and pulling the coupler throughtissue. In this test, the force on the coupler was found to be 11 bs.Additional tests in animal tissues supported the belief that the forceon the coupler as it moves through tissue is between about 3 and about12 pounds. As a result, the Separation Force of this example is withindesired limits.

EXAMPLES OF SURGICAL PROCEDURES

Several methods are contemplated herein. Procedures that addressproblems other than incontinence (e.g. cystocele, enterocele orprolapse) are also contemplated alone or in conjunction with the presentinvention. Further, the term “urethra,” with respect to slingpositioning, is used for brevity and reader convenience. It should benoted that the present invention is particularly suitable for placing asling in a therapeutically effective position. The method may beutilized to support a variety of structures at different anatomicallocations. As such, the terms “target site,” “bladder”, “urethro-vesicaljuncture”, “vaginal vault”, “U-V juncture” and “bladder neck” are alsoincluded within the scope of the present invention.

The present invention includes surgical procedures that utilize thenovel surgical instruments and articles described above. The presentinvention also includes improved surgical sling procedures.

The present invention preferably utilizes a suprapubic approach, atleast initially. A suprapubic approach affords greater control over theend of a needle to avoid areas with sensitive vascular structures andthe obturator nerves. Further the heightened control associated with acaudad passage is believed to avoid injury to bowel tissue.

Referring now to FIGS. 13 through 20, a preferred embodiment of surgicalprocedure is disclosed. Initially, the patient is placed under local,spinal or general anesthesia. A small transverse incision 404 is made inthe anterior vaginal wall 20 of a female patient followed by atransurethral dissection. Two small transverse suprapubic abdominal stabincisions 400 are also made near the back of the pubic bone (e.g. eachabout 1 cm from the midline, or alternatively, one large incision may bemade) to allow for needle entry. Optionally, two paraurethraldissections (incisions next to the urethra) lateral to the midline maybe created to allow the surgeon's finger to meet the end 58 of theneedle 60 during the procedure.

A handle 64 may optionally be used. Alternatively, the needle 60 can beused alone, without the handle 64. FIG. 13 shows the end 58 of needle 60just passing an abdominal incision 400. Preferably, after the end 58 ofthe needle 60 passes the suprapubic abdominal incision 400, the surgeonseeks to encounter resistance associated with the posterior portion ofthe patient's pubic bone 402 with the end 58 of the needle 60 tocontrollably move the end 58 of the needle toward the vaginal incision404 and to help avoid damaging structures such as the urethra andbladder of the patient. The end 58 of the needle 60 is used to identifythe location of the pubic bone 402. The surgeon exploits the resistanceprovided by the pubic bone 402 to controllably pass the end of theneedle 58. This approach is preferred as it helps keep the needle 60away from major pelvic vessels, nerves and anatomical structures such asthe urethra, bowels and bladder.

FIG. 14 illustrates the end of the needle as it just passes thesuprapubic incision. FIG. 15 illustrates the needle 60 as the surgeonbegins to experience the tactile feel of the resistance provided in partby the posterior portion of the pubic bone 402. FIG. 15 shows the needle60 as it passes in proximity to the posterior surface of the pubic bone402 which continues to operate as an anatomical guide for the surgeon asthe needle end 58 approaches vaginal incision 404 (see FIG. 16).

FIG. 16 illustrates the needle as it passes out of a vaginal incision404. Optionally, with the index finger of a hand, the surgeon may meetthe end 58 of the needle via the paraurethral dissection. The surgeon'sfinger may be delicately placed adjacent endopelvic fascia of thepatient and used to guide the needle 60 through the relatively toughendopelvic fascia and into the vaginal incision 404. This helps thesurgeon keep away from structures such as the bladder, urethra and othersensitive tissue.

The small diameter and curvature of the needles 60 help to provideprecise passage of the needles 60 to the vaginal incision 404. Inaddition, this needle configuration creates a minimally invasive pathwaythrough tissue extending between the abdominal wall and pubic space,thereby reducing the risk of perforating the bowel and/or blood vesselsand nerves located lateral to the bladder 14.

The steps described above are preferably repeated as needed for a secondneedle 60 on the other side of the urethra 16. Once both needles areplaced, surgeons typically perform a cystoscopy to ensure that thebladder is not punctured before implanting the sling. A cystoscopyconfirms the integrity of the bladder 14 and urethra 16 or recognizes abladder perforation.

FIG. 17 is a perspective view of a sling associated with two needles 60.Adapters (e.g. couplers 54) are pushed onto the ends 58 of needles 60 asshown in FIG. 17. The couplers 54 are preferably snapped irreversiblyinto place for a secure connection. Next, if a synthetic sling assembly(such as the sling assembly of FIG. 1) is used, the plastic sheath 44 isoriented so that the optional center orientation indicia (e.g. a bluemark) is facing away from the surgical field, toward the surgeon

After the couplers 54 are attached to the needles 60, the sling assembly46 is properly oriented so that the sling assembly 46 is not twistedwhen attached to the couplers 54. Once the couplers 54 are securelyattached, the needles are pulled up through the suprapubic incisions,taking care to avoid contact with sensitive tissue. The sling is thenclamped with surgical clamps (not shown). During this portion of theprocess, the attached couplers 54 and sling assembly 46 areatraumatically pulled up through the needle paths, advancing the slingassembly 46 adjacent to and looped beneath the urethra 16 or targetsite. A portion of each end of the sling assembly 46 extending beyondthe suprapubic incisions 400 is clamped and then cut to release theneedles 60 and attached couplers 54.

The sling is placed in a therapeutically effective position. The preciseanatomical position will depend upon a variety of factors including thetype and degree of anatomical damage or insufficiency, whether the slingprocedure is combined with other procedures and other surgeon decisions.Typically, the sling is placed midurethra, without tension, but inposition to support the midurethra. Alternatively, the sling could beplaced to support the bladder neck and/or UV junction.

Once the sling assembly 46 is carefully positioned under the midurethraor target site to provide sufficient support to the target site, theoverlapping portion of the sheath 44 located near the center of thesling assembly 46 and optional member 66 (i.e. tensioning filament) maythen be used to center and properly position the sling assembly 46 underthe midurethra. The sheath 44 is then removed.

FIG. 18 shows the sling being tightened during the surgical procedure.Sling tension may be tightened by placing a device, such as a clamp,across one or both ends of the sling 42, suprapubically. Generally, thesurgeon grasps the mesh adjacent the suprapubic incision 400 and pullsupward to increase the degree of tightness of the mesh. FIG. 18 showsthe sling after the couplers have been cut off, but prior to finaltrimming.

After the couplers 54 are trimmed off, the plastic sheath 44 is removedfrom the sling mesh 42 by pulling up on both sides of the sheath 44,preferably one at a time. Optionally, to avoid overtightening the slingmesh 42 while removing the sheath 44, a forceps or other bluntinstrument may be placed between the sling and the urethra. The forcepsor other blunt instrument may be used to help establish a tension freeaspect of the sling.

In another embodiment of the invention, shown with reference to FIG. 21,a method includes the steps of: providing at least one suprapubic orabdominal needle 602 with a relatively small diameter (e.g. less than 4mm), and at least one sling associated needle 604, a sling 610 attachedto the sling associated needle 604, and an adapter (e.g. coupler 54)having sling associated needle receiving surfaces (e.g. an end ofinnerpassageway 96 near the end of the coupler having hole 90) forreceiving the end of the sling associated needle 604. For example, thesling associated needle 604 and sling 610 may comprise a TVT needle andsling available from Ethicon of New Jersey.

The method includes the steps of creating at least one vaginal incision404, creating at least one suprapubic incision 400, and initiallypassing the suprapubic needle 602 through the suprapubic incision 400and then through the vaginal incision 404, and connecting the adapter 54to the needle 602 in a substantially axial fashion.

After being attached to a coupler, needles 604 are initially passedthrough vaginal incision 404 and toward one of the suprapubic incisions400. While inserting the needles 604 initially through the vagina is notpreferred, it is within the scope of the present invention, as somesurgeons may prefer this approach due to previous surgical training,custom or personal preference. The method includes the step of placingthe end of the sling associated needle 604 in an end of the coupler 54,and then moving the sling associated needle 604 from the vaginalincision 404 to the suprapubic incision 400 with at least the guidanceof the suprapubic needle 602 to implant the sling 610. Handle 620 may beconnected to a sling attachment end of needle 604 for this purpose.Guiding the end of the large sling associated needle 604 in this fashionis believed to help avoid contact between the sharp tip of needle 604and sensitive structures such as obturator nerves, and vascularstructures such as the superficial epigastric vessel, the inferiorepigastric vessel, the external iliac artery and the obturator.Optionally, the coupler and sling associated needle 604 may includecomplementary engagement surfaces for securely attaching the needle 604to the coupler 54 (and hence to the needle 602).

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. An assembly for treating fecal incontinence comprising: an elongateneedle that is sized and shaped to be initially inserted through anabdominal incision and to then emerge from at least one other incision,the needle having an insertion end and an end opposite the insertionend, a sling for implantation in the body during a fecal incontinenceprocedure, and a coupler having an axis, the coupler having a first endand a second end with surfaces for conveniently and securely connectingthe coupler to the insertion end of the needle by moving the coupler andinsertion end of the needle together.
 2. An assembly according to claim1 wherein the coupler is connected to needle by being moved together ina substantially axial fashion.
 3. An assembly according to claim 2wherein after the needle is connected to the coupler, the assembly has aSeparation Force of at least about fifteen pounds.
 4. An assemblyaccording to claim 3 wherein after the needle is connected to thecoupler, the assembly has a Separation Force of at least about thirtypounds.
 5. An assembly according to claim 2 wherein the assembly has anInsertion Force of no more than about fifteen pounds.
 6. An assemblyaccording to claim 5 wherein the assembly has an Insertion Force of nomore than about ten pounds.
 7. An assembly according to claim 6 whereinthe assembly has an Insertion Force of no more than about eight pounds.8. An assembly according to claim 1 wherein the coupler is sized andshaped to be connected to the needle after the insertion end of theneedle emerges from the at least one other incision.
 9. An assemblyaccording to claim 1 wherein the sling includes an insertion sheath andthe first end of the coupler is attached to the sheath.
 10. An assemblyaccording to claim 1 wherein the tip of the insertion end of the needleis substantially blunt.